Check out in this article how the Electronic Batch Records (EBR) assists pharmacists in ensuring compliance with your product.

To produce products with quality and safety, industries generate records all the time. These are records of production, analyzes, maintenance, nonconformities, in short, any data that can guarantee the traceability of the batch and evidence of verification.

Legislation around the world requires manufacturers, especially pharmaceuticals, to have evidence of proper handling within all stages of the production process. The Food and Drug Administration, popularly known as FDA, for example, brings the minimum requirements of Good Manufacturing Practices that a manufacturer must meet to ensure that its products are consistently of high quality, from batch to batch within their intended use. One of these requirements is the preparation and retention of batch production and control records.

The batch record is a document that collects all data and information to make a regulated product. These records collect data on materials, dates, equipment, people, analysis, inspections, labels and events during the production of the products.

What should be in the records?

Some data are extremely important and should be included in the main records generated by organizations. The following details some of these main data:

  • Product batch;
  • Production date;
  • Equipment used;
  • People involved in the production of that batch;
  • Quantity and batch of each raw material used;
  • Calibration of equipment such as scales and thermometers;
  • Batch number and the quantity of any recovered or reprocessed material added to the process;
  • Process controls;
  • Hygiene of equipment, area and utensils before and after production;
  • Data on the distribution of the product – quantity, customer, day, time;
  • Information on the conditions of delivery of each raw material as well as each sale of the product, mainly related to the cleaning and structure of the vehicle;
  • Pest control data.

All this information certainly does not need to be included in a single record, but must be reported in a way that all data is traceable and related. Still, there are some characteristics that all records must have to be considered valid and true:

  • Attributable – Checks the cause, authorship or possession of something
  • Legible – Immediate identification, no doubt
  • Contemporary – Registered at the time of the occurrence
  • Original – Original, primary and authentic
  • Accurate – Precise, refined, enhanced

The quality area uses the batch record to review whether the manufacturing process followed the standard operating procedures (SOP), the critical quality attributes and the process parameters that are critical (CCP). In addition, they are also used to investigate deviations during production in the processes of nonconformities and customer complaints.

Paper records

The most traditional way to prepare records is through paper. Organizations structure form templates that are periodically printed and delivered to those responsible for filling out the data according to the frequency already defined. These documents are then verified and approved by designated persons, usually by means of signatures and subsequently retained and stored for periods that may vary, but which are usually 5 years after the validity of the product. This whole process presents a number of possible problems that may hinder the validation of the record and not allow the traceability of the batch.

  • Incomplete data that cannot be recovered;
  • Illegible documents;
  • Loss of registration due to wear or damage;
  • Use of model in old revision;
  • Maintain a physical space for filing;
  • Expenditure on paper and printing;
  • Disorganization;
  • Incentive to deforestation due to the large amount of use on paper;
  • Employees without training on how to complete the record;
  • Forgetting registration or approval of the registration;

These and other obstacles can cause significant delays in production and major problems in product quality assurance, especially in audits and inspections of public health authorities. This is the perfect scenario that can result in complete production losses, rework or even worse in collections and recalls.

Electronic batch records (EBR)

The question is:

How to record all batch information and ensure that traceability is working in addition to producing valid and true records?

The answer is simple, through electronic records. Electronic batch records simplify the tracking and management of production data. Regulated sectors are getting increasingly better as they move from paper-powered factories to digital and modern smart factories, through the implementation of batch electronic record software.

A batch electronic system, also known as Electronic Batch Record (EBR), helps maintain data integrity, save time, reduce human error and ensure product compliance.

But are these electronic records authorized by the competent bodies that regulate medication? Well, according to the regulation found in 21 CFR Parts 210-211, the EBR must demonstrate the achievement of all significant steps. This includes the production, packaging and retention of each batch of medication. That is, its use is fully allowed as long as the computerized system follows all the premises of its regulation that include: an audit trail with date / time stamp, reports, electronic signature and security requirements.

An electronic batch record uses multiple databases that capture information that is recorded during the manufacture of a batch. Furthermore, it is possible to associate with a business process modeler (BPM) mechanism that defines the process to be followed, ensuring that it follows exactly the path it must go through within the organization, from the factory floor to approval by leaders and supervisors since the tool also allows electronic and digital signatures.

The choice of technological solutions has been a victory and a growth in the digital transformation of pharmaceutical companies to go beyond compliance with good manufacturing practices.

SoftExpert Excellence Suite

The SoftExpert Excellence Suite is a complete tool when it comes to assisting organizations in implementing an EBR system. Through forms and customized process automation the software guarantees the conformity of the product, improving the efficiency of the activities and ensuring the entire traceability of the data.

Contact SoftExpert specialists. They will understand the main challenges of your institution and propose the best way to implement a technological platform to meet your needs.

Find out more about SoftExpert Excellence Suite

Camilla Christino


Camilla Christino

Camilla Christino é Analista de Produto e Mercado da SoftExpert, formou-se em Engenharia de Alimentos no Instituto Mauá de Tecnologia. Detém sólida experiência na área de qualidade em indústrias de alimentos com foco em acompanhamento e adequações de processos de auditorias interna e externa,documentação do sistema de gestão da qualidade (ISO 9001, FSSC 22000, ISO/IEC 17025), Controle da Qualidade, Assuntos Regulatórios, BPF, APPCC e Food Chemical Codex (FCC). Ela também é certificada como auditora líder na norma ISO 9001:2015.

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